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RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR FOR RESEARCH IN PROGRESS

The final letter of approval sent to the principal investigator outlines the continuing responsibilities that the investigator has to the IRB while the research is being conducted. These responsibilities include:

  1. conduct the study only according to the protocol approved by the IRB;
     
  2. promptly report to the IRB all events or problems if the event or problem meets definition of an unanticipated problem involving risk to subjects or others (UPIRSO - unanticipated and serious and at least possibly related and involves risk to subjects or others) (Use the UPIRSO wizard to see if prompt reporting is required)
     
  3. Non-prompt reporting: Report event or problem as part of the continuing review (which constitutes non-prompt reporting) if the event or problem is UNANTICIPATED AND SERIOUS AND at least possibly RELATED but does not involve risk to subjects or others (an optional tracking form has been created to assist in tracking events or problems to be reported during continuing review);
     
  4. reporting is not required for the other findings (see detailed guidance below) but they may also be listed/summarized as part of the continuing review of the study (an optional tracking form has been created to assist in tracking events or problems to be reported during continuing review)
     
  5. ensure that only formally designated investigators (as approved by the IRB) enroll subjects using the most current IRB stamped consent form;
     
  6. ensure that only appropriately qualified clinicians make study-related health care decisions
     
  7. protect the confidentiality of all personally identifiable information collected and train your staff and collaborators on policies and procedures for ensuring confidentiality of this information;
     
  8. submit for review and approval by the IRB all modifications to the protocol or consent form(s) prior to the implementation of the change using the amendment form;
     
  9. submit a Progress Report for continuing review by the IRB. Federal regulations require IRB review of on-going projects no less than once a year (a Progress Report will be sent to you 2 months prior to the expiration date-IRB review will occur within 30 days of expiration to maintain a fixed study expiration date in accordance with OHRP guidance); and
     
  10. notify the IRB when the study has been completed and prepare a final report.